RecruitingShoulder OsteoarthritisShoulder Arthritis
AETOS Shoulder System
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
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About this study
The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization
Sponsor: Smith & Nephew, Inc.
You may qualify if…
- ✓ Patients must meet all the following criteria to be included in the study:
- ✓ 1. Patient is at least 18 years of age at the time of consent and skeletally mature.
- ✓ 2. Patient is undergoing a primary elective anatomic or reverse shoulder replacement surgery for one of the following indications:
- ✓ Rheumatoid arthritis, and/or
- ✓ Traumatic arthritis (Post Traumatic arthritis), and/or
- ✓ Non-inflammatory degenerative joint disease, and/or
- ✓ Correction of functional deformity.
- ✓ 3. Patient is willing and able to accommodate all study-related procedures and visits detailed in the protocol \& cooperate in the standard of care post-operative therapy.
You may not qualify if…
- ✕ Patients who meet any of the following criteria will not qualify for participation in the trial:
- ✕ 1. Patient has a contraindication to AETOS.
- ✕ 2. Patient is undergoing a revision shoulder replacement surgery including total or partial arthroplasty.
- ✕ 3. Patient is indicated for a Hemiarthroplasty.
- ✕ 4. Patient has traumatic injury or a fracture.
- ✕ 5. Patient has uncontrolled diabetes with a hemoglobin A1C of 7.5 or greater.
- ✕ 6. Patient has comorbidities/conditions that preclude proper healing/fixation of the implant.
- ✕ 7. Patient has poor quality or insufficient bone stock to support the implant.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06319911 · last updated 2024-05-07